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After Covis' Makena pull, EU regulator flags safety and efficacy problems with similar preterm birth drugs

Fierce Pharma

A committee of the European Medicines Agency on Friday called for the withdrawal of preterm birth drugs containing 17-hydroxyprogesterone caproate (17-OHPC), citing safety and efficacy concerns. Following a controversy over Covis’ preterm birth drug Makena in the U.S.

Safety 294
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Gilead's Tecartus gets revised safety demand amid FDA's push for CAR-T boxed warnings

Fierce Pharma

Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. . | The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Instead, it's adjusted the wording of a proposed boxed warning.

Safety 275
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From Recalls to Reliability: Tools to Ensure Software Safety in MedTech

MedCity News

The post From Recalls to Reliability: Tools to Ensure Software Safety in MedTech appeared first on MedCity News. Cutting-edge technology empowers developers to proactively detect and mitigate issues before they cause problems, reducing recalls and fostering trust in the industry.

Safety 93
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CSL Vifor proposes campaign to undo messaging about safety profile of rival product

Fierce Pharma

CSL Vifor has proposed to launch a campaign that would undo the potentially misleading messages it sent about the safe | CSL Vifor has proposed to launch a campaign that would undo the potentially misleading messages it sent about the safety of a rival product, the European Commission (EC) said.

Safety 147
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Commercial Drug Sourcing for Clinical Trials

Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others.

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Novo Nordisk, Eli Lilly face scrutiny from EU's drug regulator over GLP-1 safety

Fierce Pharma

The EMA is scrutinizing GLP-1s, raising a safety signal about the risk that drugs from Novo Nordisk, Eli Lilly and other companies could cause cancer.

Safety 319
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Right-to-Repair Laws Could Threaten Healthcare Safety

MedCity News

The post Right-to-Repair Laws Could Threaten Healthcare Safety appeared first on MedCity News. Healthcare devices must be exempted from general right to repair legislation.

Safety 114
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Revvity Signals provides a centralized analytics platform built to support today’s clinical study requirements and increase trial efficiency, glean actionable analytic insights, automate data collection and harmonization, support safety and efficacy decision-making, and enable a singular view across a company’s entire candidate portfolio.

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How Machine Learning Drives Clinical Trial Efficiency

Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.